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sipuleucel-T

FDA Drug Profile — PROVENGE

Drug Details

Generic Name
sipuleucel-T
Brand Names
PROVENGE
Application Number
BLA125197
Sponsor
Dendreon Pharmaceuticals LLC
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
SIPULEUCEL-T

Indications and Usage

1 INDICATIONS AND USAGE PROVENGE ® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. ( 1 )